Principal Research Scientist I/II, CMC Purification Development

Allergan; South San Francisco (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player seeks a Senior Scientist I for its Biologics CMC Development team in South San Francisco. This role is pivotal in advancing complex biologic therapies through robust purification processes. You will leverage your extensive experience in purification and chromatography to lead projects from development to clinical studies. This position thrives in a collaborative lab environment, where your expertise will directly influence the success of novel oncology drugs. Join a team dedicated to innovation and excellence in the biopharmaceutical field, where your contributions will make a significant impact on patient care and therapeutic advancements.

Benefits

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Qualifications

• 14+ years of experience in purification process development.
• Expert in monoclonal antibodies and chromatography techniques.
• Strong communication skills and experience in technical writing.

Responsibilities

• Lead development and optimization of purification processes.
• Generate scientific proposals and evaluate new technologies.
• Mentor and supervise team members to achieve project goals.

Skills

Purification process development

Chromatography separations

Filtration operations

Principal investigator skills

Technical writing

Scientific communication

Creative problem-solving

Attention to detail

Education

Bachelor's degree in chemical engineering

Master's degree in bioengineering

Ph.D. in a related field

Tools

AKTA chromatographic instruments

Microsoft Office

HPLC

ELISA

Mass spectrometry

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs.

As one of CMC purification development group leaders, you will apply your strong expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. You will be responsible for all aspects of CMC purification program deliverables and help drive drugs substance purification development strategy through program lead assignments in cross-functional CMC teams.

This position is an onsite role in a lab-based function. To be successful, candidates must enjoy and thrive in an onsite, face-to-face, highly collaborative lab environment.

Responsibilities include:

1. Effectively function as a principal investigator, generating original technical ideas and development strategies.
2. Lead development, optimization, and scale-up of purification processes for biologics candidates to support early and late-stage development.
3. Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific advances and respond with appropriate new strategies. Conceive and evaluate novel advanced separation technologies and techniques.
4. Lead purification strategy for biologic candidates and take accountability for project deliverables.
5. Independently responsible for project science within his/her area of expertise on one or more project teams.
6. Represent purification development team and actively influence development strategy on cross-functional CMC teams.
7. As a group leader, make significant contributions to the project team through lab-based activities and execute lab and pilot scale operations to meet project deliverables.
8. Proactively seek out new tools, techniques and strategies to implement into individual programs(s) as well as the overall downstream platform.
9. Transfer processes to GMP manufacturing.
10. Work with contract labs and carry out viral clearance studies.
11. Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences.
12. Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.
13. Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

Qualifications

Basic:

1. Bachelors, Masters, or Doctorate (Ph.D.) degree in chemical engineering, bioengineering, or a related field, with at least 14+(BS), 10+(MS), or 6+(PhD) years of experience in purification process development.
2. Recognized and sought out as a downstream process development expert in his/her discipline within the company and possibly externally.
3. Must be a subject matter expert in purification of monoclonal antibodies (mAb) or other mAb-based biologics including chromatography separations and filtration operations (depth, dead-end, virus, and ultrafiltration/diafiltration).
4. Expert user of AKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure, AKTA Ready or similar).
5. Must have excellent attention to detail and ability to keep detailed written records.
6. Direct experience in designing, planning and executing virus clearance studies.
7. Demonstrated ability to function as a principal investigator, generating original technical ideas and development strategies.
8. Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
9. Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators.
10. Demonstrated ability to influence others across areas of scientific disciplines.
11. Must have strong communication skills including verbal, written, and scientific data presentation.
12. Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
13. Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
14. Has proficiency with Microsoft Office software, ability to learn new software applications.

Preferred:

1. Strong understanding of analytical techniques using HPLC, ELISA and mass spectrometry based methods.
2. Proven experience in chromatography or membrane separation mechanistic modeling.
3. Experience in developing and executing high throughput process and/or lab scale process automation tools.
4. Direct experience with execution of downstream processes at GMP and/or pilot scale for mAb or other mAb-based biologics.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

1. The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
2. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
3. This job is eligible to participate in our short-term incentive programs.
4. This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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